Michael Amar Email
Internationnal regulatory affairs @ Rafa Laboratories
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Michael Amar Location
- Israel
Michael Amar Work
- Internationnal regulatory affairs @ (February 2020 - Present)
- R and D Project Manager @ (December 2015 - December 2019)
- Stemcell Medicine Ltd. Responsible Pharmacist QP and Regulatory Affairs Pharmacist @ (December 2015 - December 2019)
- Regulatory Affairs, Deputy QP and Deputy QP PV Pharmacist @ (January 2014 - November 2015)
- R and D Project Manager and Responsible Pharmacist @ (June 1998 - June 2012)
- Pharmacist @ Superpharm (December 1996 - May 1998)
- Pharmacy school 6th year and DEA (a postgraduate degree granted 5 years @ Structural Biology & Protein Engineering dep, National Scientific Research Cente (January 1995 - June 1995)
Michael Amar Education
- Oulpan Etsion Jerusalem
Hebrew intensive courses
1996-1996 - University Paul Sabatier Toulouse III
Master with These (Molecular modeling)
1993-1995 - University Paul Sabatier Toulouse III
State Diploma of Doctor in Pharmacy (Industry and Research specialization)
1988-1995 - Fermat high school in Toulouse 1987-1988
- Israeli Health Ministry
Appointed Pharmacist approval (based on previous working experience)
2013 - Israeli Health Ministry
QP course exemption approval (based on previous working experience)
2013 - Israeli Health Ministry Pharmacists Licence exam
Pharmacists Licence
1996 - High School Muret
High School Diploma (Mathematics & Physics)
Michael Amar Skills
- 14 years experience in Generic drugs formulation development
- Scale up and process validation
- CTD format Registration file redaction according to EU and IL guides
- Submission strategy determination and answer to defficiency letters
- Familiar with JV with Eueopean generic companies like STADA GmbH
- 9 years experienced Responsible Pharamcist exempted from QP courses
- Pharmacist diplomed from France (EU) able to be QP for EU
- French: mother tongue
- English: working knowledge
- French
- V&V
- Determination
- Redaction
- English
- Generic Drugs
- Regulatory Affairs
- Formulation
- Pharmaceutical Industry
- FDA
- Regulatory Submissions
- CAPA
- Generic Programming
- Validation
- R&D
- GMP
Michael Amar Summary
- Michael Amar, based in Israel, is currently a Internationnal regulatory affairs at Rafa Laboratories. Michael Amar brings experience from previous roles at Mapi Pharma, Tec-O-Pharm Group and Dexcel Pharma. Michael Amar holds a 1996 - 1996 Hebrew intensive courses @ Oulpan Etsion Jerusalem. With a robust skill set that includes 14 years experience in Generic drugs formulation development, Scale up and process validation, CTD format Registration file redaction according to EU and IL guides, Submission strategy determination and answer to defficiency letters, Familiar with JV with Eueopean generic companies like STADA GmbH and more. Michael Amar has 3 emails on RocketReach.
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